This pilot study will establish the feasibility of a larger trial to investigate whether reboxetine, a medication used to treat depression, can reduce the severity of obstructive sleep apnea (OSA) including increased blood oxygenation in post-surgical OSA patients where positive airway pressure (CPAP) therapy is either frequently poorly tolerated or not an option immediately post surgery. In this randomized, placebo-controlled, double-blind study, participants will use at-home sleep monitoring equipment before and after surgery plus measures of oxygenation. They will be prescribed either reboxetine or a placebo for seven days after surgery and complete questionnaires at the beginning and end of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
20
7 nightly doses (4mg) to commence after surgery.
7 nightly doses to commence after surgery.
Flinders, Private and Public Hospitals and Flinders University
Bedford Park, South Australia, Australia
RECRUITINGTreatment protocol adherence
The percentage of total doses of the study drug (reboxetine or placebo) that were taken versus prescribed (assessed via pill counts) for this feasibility study.
Time frame: 7 days
Data capture efficiency
The percentage of successful data collection nights versus missed nights of at-home oximetry for this feasibility study.
Time frame: 14 days
Oxygen desaturation index (ODI)
Number of times per hour that a participant has a drop in blood oxygen levels during sleep
Time frame: 14 days
nadir SpO2
The lowest oxygen saturation value the patient drops to in a night.
Time frame: 14 days
Time spent below 90% SpO2
The total amount of time per night for which oxygen saturation falls below 90%.
Time frame: 14 days
mean SpO2
Average nightly oxygen level
Time frame: 14 days
Sleep duration
Total amount of time spent asleep per night, sleep tracking performed using an under mattress sensor device.
Time frame: 14 days
Sleep efficiency (%)
The estimated percentage of time in bed spent asleep performed using an under mattress sensor device.
Time frame: 14 days
Daytime sleepiness
Measured via Karolinska Sleepiness Scale Questionnaire (9 point scale where 1 = extremely alert and 9 = extremely sleepy - fighting sleep)
Time frame: 14 days
Perceived sleep quality measured via the Leeds Sleep Evaluation Questionnaire
This questionnaire asks participants to rate their perceived sleep across 4 domains on a visual analog scale as follows: 1) getting to sleep, 2) quality of sleep, 3) Awake following sleep, 4) Behavior following wakening. Higher scores indicate better perceived sleep.
Time frame: 14 days
Insomnia Severity Score
A patient-reported measure of insomnia symptoms using the Insomnia Severity Index- A 28 point scale where 0 indicates no clinically significant insomnia and 28 indicates maximally severe clinical insomnia.
Time frame: 14 days
Apnoea-hypopnea hndex (AHI)
Change in OSA severity (AHI estimated via the Withings under mattress sensor number of events/hour) between placebo and reboxetine
Time frame: 14 days
Study enrolment rate
The number of referred patients successfully enrolled into this feasibility study
Time frame: 12 months
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